Alzheimer’s Vaccine Candidate Shows Positive Phase 2a Results
United Neuroscience Alzheimer's vaccine UB-311 produced positive results for 96 percent of phase 2b study participants
United Neuroscience (UNS) announced positive top-line results from its Phase 2a clinical study of UB-311, a novel synthetic peptide vaccine candidate targeting beta amyloid (Aβ) in the treatment of Alzheimer's disease.
This is important news since active vaccination of human individuals against Aβ has yet to be safely and effectively achieved.
The Phase 2a double blinded, placebo-controlled study evaluated the safety and immunogenicity of prolonged dosing with 2 different dosing regimens of the Alzheimer’s vaccine candidate showed that 96 percent of patients responded positively, without serious side effects.
All secondary endpoints - including Amyloid PET burden, CDR-SB, ADCS-ADL, ADAS-Cog, and MMSE - pointed directionally in favor of UB-311, though not statistically significant with the study sample size.
UB-311 is a novel UBITh™ active vaccine targeting the N-terminus of Aβ peptides and is designed to induce high B-cell specific responses while avoiding T-cell inflammation.
"The positive results show that we can safely raise and maintain anti-Aβ antibody titers in a predictable and sustained manner," said Peter Powchik, Executive Vice President of Research and Development at UNS.
"High response rates, reproducibility of response and generation of antibodies directed to relevant toxic protein species are key elements of an effective therapeutic vaccine for neurodegenerative conditions.”
The subjects from the completed Phase 2a study will roll over into a long-term extension study and will be offered continued treatment with UB-311.
In the Phase I study, UB-311 vaccination safely elevated anti-Aβ antibodies in all patients with a suggestion of cognitive stabilization.
Recent Alzheimer's disease news articles:
- An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
- United Neuroscience Announces Positive Top-Line Results from Phase 2a Clinical Study of UB-311 Vaccine in Patients with Alzheime
- United Neuroscience Presents Data for Phase 2 Active Vaccine Program UB-311 at the Clinical Trials on Alzheimer's Disease 2017 M
- UB-311, a novel UBITh® amyloid β peptide vaccine for mild Alzheimer's disease